Nasal support device for animals and method

ABSTRACT

Devices and methods for facilitating air flow in the nasal passages of domestic animals are disclosed. The devices include support devices for supporting unsupported tissues of the nasal passages which facilitate air flow during rest, physical exertion, respiratory ailment, etc. Components and methods to facilitate application of the support device to the nose of an animal are also disclosed.

FIELD OF THE INVENTION

[0001] The present invention is directed to facilitating air flowthrough the nasal passages of an animal. Specifically, the inventionprovides nasal support devices and methods for supporting soft tissuestructures of the nasal passages of an animal.

BACKGROUND OF THE INVENTION

[0002] Portions of the following discussion of the nasal anatomy ofdomestic animals are excerpted from R. Nickel et al., The Viscera ofDomestic Mammals, (2 nd revised ed.), Springer-Verlag, N.Y., Hiedelberg,Berlin (1979), pp. 211-221. This is an excellent text on the comparativevisceral anatomy of domestic mammals. As used herein. the terms “mammal”and “animal” are used synonymously and refer to non-human mammals.

[0003] The nasal anatomy of animals is considerably different than thatof a human. Unlike the human nose that projects distinctly from theface, in many animals, the nose is incorporated into the face and formsthe large dorsal and lateral areas rostral to the eyes. The nostrils atthe apex of the nose are the entry to the respiratory system. Oncepassing through the nostrils, inspired air moves through the nasalcavities and continues into the nasopharynx, larynx, trachea and lungs.

[0004] At the apical entrance to the nose the nostrils are partitionedby the nasal septum to divide the nasal cavity into right and lefthalves. The caudal portion of the septum is typically bony, whilerostrally the septum consists of cartilage which becomes progressivelymore flexible toward the apex.

[0005] The wall of the nose consists of skin externally and a middlesupporting layer of bone caudally and cartilage rostrally. The nasalcavity is lined by a mucous membrane. The rostral bones forming the wallof the nose include the nasal, maxillary and incisive bones. The freeborders of the nasal and incisive bone provide attachment for thecartilages which support the nostrils. The supporting bones andcartilages of the nose are associated with the nasal muscles thatregulate the size of the nostrils.

[0006] The dorsal and ventral lateral nasal cartilages are formed by thewidening of the rostral part of the nasal septum along its dorsal andventral margins. In the horse, the ventral lateral nasal cartilage issmall and may be absent. In many domestic animals, there is no lateralsupport for the soft tissue over the rostral nasal passage caudal to thenostril.

[0007] A further difference in the formation of the nasal cartilages ofthe horse is the presence of alar cartilages. The alar cartilagesconsist of a ventral cornu and a dorsal lamina and support the nostrilsdorsally, medially and ventrally. The lamina of the alar cartilage andthe medial accessory cartilage support the nasal diverticulum, a blindpouch in the dorsal aspect of the nostril.

[0008] The muscles of the nose and upper lip act to dilate the nostrils.This is particularly noticeable during labored breathing. In the horse,these muscles are well developed and can transform the normallysemilunar nostrils to become circular.

[0009] The dorsal lateral area of the rostral nasal cavity that iscaudal to the alar cartilages of the horse includes a region ofunsupported soft tissue which can be drawn into the nasal cavity duringinspiration of air into the nasal passages. The nasal diverticulum ofthe horse is a part of the soft tissue structures of the horse which canbe drawn into the nasal cavity. When the soft tissue is drawn in, it cannarrow the nasal cavity and reduce the area for the intake of air, thusreducing the air movement into the nasal passages and ultimately to thelungs where the oxygen is transferred in the pulmonary aveoli.

[0010] The physiological effects of reduced oxygen transfer at rest andduring physical exertion in horses are documented. Some experts havetheorized that exercise induced pulmonary hemorrhage (EIPH) inperformance horses is caused by asphyxia due to abnormal resistance of aclosed or partially closed upper airway. The upper airway being definedas the region of the respiratory tract lying between the nostrils andthe windpipe at the level of the first rib. Dr. Robert Cook, “EIPH orAIPE? A Tufts University Researcher suggests that bleeding is not causedby EIPH, but by asphyxia”, The Equine Athlete, p. 22-23 (Mar./Apr.1997).

[0011] Devices for dilating the outer wall tissue of the nasal passagesin humans are known and described in, for example, U.S. Pat. Nos.5,476,091; 5,533,503; 5,546,929; 5,549.103; 5,553.605; 5.611,333; and5,653,224. Devices for supporting outer tissues of the nasal passages ofanimals must address the unique soft tissue and mechanicalcharacteristics of an animal nose, particularly performance animals suchas horses, camels and dogs. Support devices for the nasal passages ofanimals are known and described in U.S. Pat. No. 5,913,873 andInternational Patent Publication WO 98/47451. The entire disclosure ofthe foregoing patent and patent application are incorporated herein byreference.

SUMMARY OF THE INVENTION

[0012] The present invention provides support devices and methods forsupporting the unsupported nasal tissues of an animal. In addition toproviding features which enhance the function of a support device duringuse, the invention also provides components to facilitate the ease andaccuracy of positioning a device on an animal's nose. The inventionfurther provides features which address some of the needs which arisewhen using a support device during certain competitive events. It willbe appreciated that some of the components or features of the hereindisclosed devices may also be applicable for use with human nasaldilators.

[0013] Throughout the specification, guidance may be provided throughlists of examples. In each instance, the recited list serves only as arepresentative group. It is not meant, however, that the list isexclusive.

[0014] In general, a support device according to the invention providessupport to the right and left lateral vestibular walls of a domesticanimal. The device can also include a surface layer, a support layer,and an engaging layer. The support devices included can also include acarrier layer to facilitate handling and positioning of the device on ananimal's nose. In some preferred embodiments, the support device is adark color.

[0015] In alternative embodiments, the invention provides facilitationto air flow in the nasal passages of an animal by supporting the caudalapex region of the vestibular walls of the animal.

[0016] The disclosed support devices can be used on an animal that isrunning free in a pasture, or wearing saddlery, harnesses or otherequipment that may be attached to the nose of the animal whileperforming physical activity.

[0017] The devices and methods of the invention are particularlyadvantageous for use in horses and are beneficial for use duringathletic performance or for reducing the occurrence, severity oreffect(s) of respiratory diseases in an adult or young animal.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1 is a top plan view of one embodiment of a nasal supportdevice according to the invention;

[0019]FIG. 2 is a profile view of the bony anatomy of the rostral nasalcavity of the horse;

[0020]FIG. 3 is a bottom exploded view of the nasal support device ofFIG. 1;

[0021]FIG. 4a is a top view of the nasal support device of FIG. 1 withthe support layer illustrated in phantom;

[0022]FIG. 4b is a top view of one embodiment of lift members accordingto the invention.

[0023]FIG. 5 is a top plan view of the nasal support device of FIG. 1having a carrier layer;

[0024]FIG. 6 is a front view of a horse having the embodiment of a nasalsupport device of FIG. 1 secured to its nose;

[0025]FIG. 7 is a top plan view of the nasal support device of FIG. 1having an alternative embodiment of a carrier layer;

[0026]FIG. 8 is a top plan view of an alternative embodiment of a nasalsupport device according to the invention;

[0027]FIG. 9 is a diagrammatic representation of an alternativeembodiment of a nasal support device according to the invention; andFIG. 10 is a diagrammatic representation of another alternativeembodiment of a nasal support device according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0028] The invention is directed to devices and methods for supportingtissues at the rostral aspect of the nasal cavity of domestic animals.Specifically, the devices and methods disclosed provide support for theunsupported region of the “vestibule” in the rostral nasal cavity. Whilethe components and features of the disclosed devices are particularlyadvantageous for animal devices, some of the components and features mayalso be advantageously used with nasal dilators for humans.

[0029] In general, a support device of the invention can be used anytimeit is desired to facilitate or enhance nasal air intake. In addition tofacilitating air flow, the support devices can also be used to treat orprevent respiratory ailments in adult or young animals. The devices andmethods of the invention may be particularly beneficial in horses forreducing the severity or effect(s) of respiratory conditions such aslaryngeal hemiplegia, chronic obstructive pulmonary disease (COPD) orexercise related pathologies such as myositis, dorsal displacement ofthe soft palate (DDSP), exercise induced pulmonary hemorrhage (EIPH),etc.

[0030] As used herein, the term “rostral” refers to that aspect of thenose closest to the apex of the nose. “Caudal” refers to that aspect ofthe nose closest to the poll or caudal aspect of the head. The“vestibule” refers to the rostral aspect of the nasal cavity that isdefined by the alar cartilages rostrally, the incisive bone ventrally,the nasal bone dorsally, the caudal intersection of the incisive andnasal bones caudally, and the nasal septum medially. The supportedregions of the vestibule are generally supported by bone or cartilage.

[0031] The “unsupported” region of the vestibule is also referred to asthe “lateral (free) wall” of the vestibule or “vestibular wall”. Thelateral wall of the vestibule includes the unsupported soft tissuedefined by the nostrils rostrally, the lateral free border of the nasalbone dorsally, the dorsal free border of the incisive bone ventrally,and the intersection of the nasal and incisive bone caudally. In thehorse, the dorsal border of the unsupported region can include thedorsal lateral nasal cartilage. In some species, the ventral border caninclude the ventral lateral nasal cartilage. For purposes herein, thevestibular wall can be divided into at least two portions, a rostralportion being that portion nearest the nostrils and a caudal portionbeing that portion nearest the intersection of the nasal and incisivebone. The region including about the caudal one quarter to one third ofthe vestibular wall is referred to as the “caudal apex region” and ismore fully described below.

[0032] Herein, “soft tissue” has its general meaning including skin,muscle, fat, connective tissue or associated integumentary structures.

[0033] Some exemplary embodiments of support devices of the inventionand components are described below. Throughout the specificationguidance may be provided through lists of examples. In each instance,the recited list serves only as a representative group. The examples ofthe groups are not meant to be limiting.

[0034] In a typical embodiment a support device provides support to atleast a portion of the right and left lateral vestibular walls of ananimal. Generally, a support device includes a right and left sidepiece, each including a support layer, which when secured to the nose ofthe animal are positioned to provide structural support to some or allof the right and left lateral vestibular walls. The “right” and “left”side pieces can also be referred to as “first” and “second” or “second”and “first” side pieces. In some embodiments, the support device isbilaterally symmetrical and the side pieces of the device meet at themidline in the midline region of the device. According to thisembodiment, when the support device is secured to the nose of an animal,the intersection of the right and left side pieces at the midlinepreferably overlie the intersection of the left and right nasal bonesand the right and left side pieces overlie the first and secondvestibular walls, respectively.

[0035] The side pieces and the midline region of the support device eachhave a rostral end, a caudal end and a rostral-poll dimension. Due tothe size and anatomical configuration of the surface area of thevestibular free wall of, for example, a horse, to provide sufficientsupport to benefit the animal, the rostral-poll dimension at the midlineregion of a support device is preferably substantially equal to orgreater than the rostral poll dimension of the side pieces. Hence, inone embodiment, the rostral-poll dimension of the midline region is atleast as great as the rostral-poll dimension of either of the sidepieces. In an alternative embodiment, the rostral-poll dimension of themidline region is greater than the rostral-poll dimension of the rightor left side piece.

[0036] As used herein, the term “support” refers to reducing the amountof narrowing of the nasal passage that can occur during inspiration orexpiration of domestic animals. Accordingly. “support” can include somedrawing in of the vestibular free wall into the rostral nasal passageduring inspiration, but less than that which would occur without adevice of the invention. “Support” also includes maintaining theposition of the external sort tissue over the rostral nasal passage in aneutral position. As used herein, “neutral” refers to a state where theunsupported vestibular tissues are neither drawn into the nasal cavitynor protruding externally relative to a resting position. In somearrangements, “support” also includes maintaining the vestibular freewall in a “distended” outward position relative to the neutral position.

[0037] The configuration. arrangement and components of a supportdevices disclosed herein takes into account the anatomical andphysiological characteristics of the vestibular free wall, the bonystructures defining the borders of the vestibular free wall, uniqueproblems presented in applying the device to an animal as well asequipment used on or around an animal wearing a nasal support device.

[0038] The size of a device of the invention can vary. Appropriate sizedevices configured for an animal typically correspond with muzzle sizewhich can vary with the body size, breed, age, and sex, of the animal.It is foreseen that smaller size support devices for young animals, suchas calves and foals can be beneficial in treating, for example, upper orlower respiratory ailments. In some embodiments, the rostral-pollmidline dimension of an NSD for an average sized adult horse is about 3to 16 cm, preferably 6-14 cm and the rostral poll dimension of the rightand left side can be about 3 to 12 cm. However, larger and smaller sizesmay be used.

[0039] The transverse dimension of an NSD can also vary. The “transversedimension” is defined as the length of the device from the lateral edgeof a first side of the device to the lateral edge of the second side ofthe device. The transverse dimension can be approximately equal at therostral and caudal edges. Alternatively, the transverse dimension canvary in a single device depending if measured, for example, along thecaudal edge, the rostral edge, or somewhere in between.

[0040] Typically, a support device according to the invention includesat least a “support layer” and an “engaging layer”. A release linerwhich is peelably attached to the engaging layer is also typicallyincluded. In some embodiments a “surface layer” can be present to coverthe side of the support layer that is away from the nose of the animalwhen the device is secured to the nose of the animal. Some embodimentscan also include a carrier layer which can be removably attached to thesurface layer to facilitate handling and proper placement of the supportdevice on an animal's nose. The exterior color of the surface layer ispreferably selected to reduce the likelihood of the device causinginterference with equipment used for determining results of a particularcompetitive event.

[0041] The support layer of the device provides the majority of thesupport for the vestibular free wall of the nasal passage. Generally,the support layer comprises one or more “lift members.” As used herein a“lift member” can be prepared from any suitable material which providesthe desired support to the vestibular free wall. Examples of suitablematerials for a lift member include thermoplastic resins, thermosetresins, shape memory metals, alloys, leather, etc. The lift member canbe an open mesh or solid material. One example of a preferred materialfor a lift member is a biaxially oriented polyester such as MYLAR®available from DuPont Films, Wilmington, Del. Other suitable materialsfor a lift member are disclosed in U.S. Pat. No. 5,913,873 andInternational Patent Publication WO 98/47451 which are incorporatedherein by reference.

[0042] In some embodiments, the lift members can be a generally uniformthickness throughout their length and width. The thickness of the liftmembers can typically be selected based on the support needed, and isgenerally the same throughout. However, the lift members can also varyin thickness in different regions of the device. In addition, a liftmember need not be the same width throughout its length. That is, a liftmember can be wider at the ends of the lift member and narrower near themidline region. Alternatively, a lift member can be wider near themidline region and narrower at the ends.

[0043] For an adult large animal such as a horse, a suitable thicknessfor a lift member prepared from polyester such as MYLAR® is about 0.008to about 0.020 inches. In one preferred embodiment, the thickness of asupport member for an average size adult horse is about 0.014 inch.

[0044] The support layer can include one or more lift members. The liftmembers can be positioned parallel to the transverse axis of the deviceand extend partially or completely to the lateral edges of the device.Three to six lift members are preferred. When more than one lift memberis used. the width, length and spacing of the lift members can varybased on the overall dimensions of the particular device. Also, thelength of the individual lift members can vary in a single device so asto traverse some or all of the dorsal-ventral dimension of thevestibular free wall. Preferably, the transverse length dimension of alift member is sufficient to traverse the midline of the animal's noseand extend to the right and left side pieces beyond the dorsal lateralnasal cartilages to support the right and left vestibular free walls. Insome embodiments, the lift members can extend beyond the ventral edge ofthe vestibular free wall to a point lateral to the incisive bone.

[0045] When using multiple lift members, the spacing between individuallift members can affect the adherence and overall functioning of thedevice. When two or more lift members are used. the width of the liftmembers and the spacing between lift members are selected for the deviceto provide the desired support to the vestibular wall with sufficientflexibility to reduce the chance of irritation due to localized pressureat leveraging points on the animal's nose. Use of multiple lift membersadvantageously provides for torsional flexibility of the device whichfacilitates function and reduces the likelihood of disengagement of thedevice when subjected to the unique mobility of an animal's vestibulartissues. In one exemplary embodiment of a support device for an averagesize adult horse, the length of the lift members can be about 4-18 cm,preferably about 9-13 cm, the width can be about 0.2 to 2 cm and thespacing between lift members about 0.2 to 2 cm, preferably about 0.3 to1.0 cm.

[0046] A support device according to the invention also includes anengaging layer. The engaging layer provides for securing the supportdevice to the animal's nose, typically, by use of an adhesive.Preferably, the adhesive is biocompatible and provides minimal or nocontact irritation when applied to the external tissues of an animal.

[0047] Suitable materials for the adhesive of the engaging layer aresingle or double coated medical tapes, transfer adhesives, liquidadhesives, pressure sensitive adhesives (PSA), etc. A release liner ispreferably applied to the adhesive of the engaging layer to cover theadhesive surface until the support device is applied to an animal. Aswill be described below, the release liner can comprise one or moresections which can be selectively removed from the engagement layer tofacilitate positioning of the support device on the nose. Examples ofsuitable adhesive systems include No. 1509 double sided medical tape,No. 9942 Hydrocolloid Skin Protective Adhesive and No. 1524 transferadhesive available from 3M Co., St. Paul, Minn. One presently preferredadhesive is Dermamed DM-2009, available from Dermamed, 381 GenevaAvenue, Pallmadge, Ohio 44278.

[0048] A support device also includes a surface layer. The surface layeris visible when the device is applied to the nose of an animal. Thus,one side of the surface layer faces the soft tissue of the animal's noseand a second side faces away from the nose. The side facing the animal'snose can include an adhesive to adhere the surface layer to the supportlayer, to the engaging layer that may be exposed between lift members ofthe support layer, or to a pad layer, if used. A suitable surfacematerial can be breathable or nonbreathable. One example of a suitablesurface layer is No. 9910 non-woven medical tape available from 3M Co.,St. Paul, Minn.

[0049] The color of the surface layer is preferably selected so as toreduce glare which can interfere with photographs taken to determine theoutcome of a performance event such as a finish line photograph taken ina horse race. Examples of suitable colors which cause reduced glare aredark colors such as black, dark blue, dark green, dark gray, dark brown,etc.

[0050] The engaging layer may extend only to the peripheral extent ofthe lift members of the support layer. Alternatively, the periphery ofthe engaging layer can extend beyond the peripheral extent of the liftmembers of the support layer (i.e., laterally, rostrally and caudally).In some preferred embodiments, the periphery of the engaging layer canextend beyond the support layer to provide improved engagement of thesupport device to the animal's nose. In one such embodiment a region ofabout 0.5 cm to 4 cm, preferably about 1.0-2.0 cm of engaging layerextends beyond the lateral extent of the lift members of the supportlayer and 1.0-3.0 cm beyond the rostral-caudal extent of the supportlayer. The surface layer typically extends the same distance beyond thelift members as does the engaging layer.

[0051] A support device according to the invention can also include a“carrier layer”. The carrier layer can be removably adhered to the sideof the surface layer away from the animal's nose. The carrier layer canbe made from any suitable material including paper, metal foil, plastic,cardboard, etc. The carrier layer is preferably adhered to the surfacelayer using an adhesive system which provides a peel resistance which isless than the peel resistance between the adhesive of the engaging layerand the animal's nose when the support device is adhered to the animal'snose. Suitable adhesive systems for adhering the carrier layer to thesurface layer are known and disclosed in, for example, U.S. Pat. Nos.3,691,140; 4,994,322; 5,266,402; 5,502,109; and 5,719,247. The entiredisclosure of each of these patents is incorporated herein by reference.One preferred adhesive is No. 9425 available from 3M Co.. St. Paul,Minn. This adhesive system is a double side tape wherein a first side ofthe tape (applied to the carrier layer) has a greater peel resistancethan the second side of the tape (applied to the surface layer) and thepeel resistance of the second side of the tape is less than the peelresistance of the adhesive between the engaging layer and the animal'snose.

[0052] The perimeter edge of the carrier layer can follow the perimeteredge of the surface layer of the support device or the perimeter edge ofthe carrier layer can extend beyond the perimeter edge of the surfacelayer. Alternatively, portions of the carrier layer can extend beyondthe perimeter edge of the surface layer and other portions follow theperimeter edge or not extend to the perimeter edge of the surface layer.Extending the perimeter edge of the carrier layer beyond the perimeteredge of the surface layer provides a region of the carrier layer whichcan be grasped for handling or removing the carrier layer from thesurface layer without contacting the adhesive of the engaging layer.Alternatively, the carrier layer can be slit to provide an internal edgeto grasp for removing the carrier layer from the surface layer. In apreferred embodiment, the perimeter edge of the carrier layer can beconfigured to provide a guide for positioning of the support device onan animal's nose.

[0053] Thus, after removal of some or all of the release liner from theadhesive of the engaging layer, the carrier layer can be grasped duringapplication of the device without contacting the adhesive of theengaging layer. Once engaged to the nose, the carrier layer can bepeelably removed from the support device. The carrier layer can also bemarked with instructions for proper positioning and orientation of thesupport device to assist the person applying the device to the animal.

[0054] In another embodiment of the invention, a support device cancomprise two separate pieces, one for supporting a portion of each ofthe right and left vestibular wall For example, only the caudal aspectof each of the vestibular walls may be supported by the device.According to one such embodiment, the support device can extend from thenasal bone to the incisive bone, across the “caudal apex region” of thevestibular wall near the intersection of the nasal and incisive bones.In an alternative embodiment, the support device can extend rostrallyover the caudal apex of the vestibular wall from a location caudal tothe intersection of the incisive and nasal bones. In another embodiment,the support device can extend from the nasal bone to the incisive bone,across the caudal apex of the vestibular wall, and extend caudally overthe intersection of the incisive and nasal bones.

[0055] Examples of support devices and methods of the invention will nowbe further described by reference to the following illustratedembodiments.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0056] Anatomical reference points and embodiments of a nasal supportdevice according to the invention will be described with reference tothe drawings, using the horse as an exemplary animal, wherein likereference numerals represent like components and assemblies throughoutthe several views. Reference to the drawings is not intended to limitthe scope of the invention to the illustrated embodiments.

[0057]FIG. 1 is a top plan view of the configuration of one embodimentof a nasal support device (NSD) 10 according to the invention.Dimensions which can be used to characterize an NSD are shown whereinletters followed by a subscript “T” are transverse dimensions. Thus,C_(T) is the caudal transverse dimension, R_(T) is the rostraltransverse dimension. S is the rostral-poll dimension of the side pieceand M is the rostral-poll dimension at the midline of the device. Thebottom plan view of NSD 10 is substantially identical to the top planview of FIG. 1 except that the support layer, shown in FIGS. 3 and 4,may be visible.

[0058] The NSD 10 includes a first side piece 1 a and a second sidepiece 1 b that intersect at the midline 2 of the midline region 2 a and2 b. In use, the rostral end 3 is oriented towards the apex of theanimal's nose and the caudal end 4 is oriented towards the eyes of theanimal. In the embodiment of FIG. 1, the midline rostral-poll dimensionM is at least equal to the rostral-poll dimension S of side pieces 1 aand 1 b. In preferred embodiments, the rostral-poll dimension of the NSDat the midline 2 is greater than the rostral-poll dimension S of thefirst or second side pieces 1 a , 1 b. It will also be appreciated thatin the illustrated embodiment ,the rostral transverse dimension R_(T) isless than the caudal transverse dimension.

[0059] Bony anatomical structures which surround the vestibular freewall which is supported by a support device of the invention aredescribed with reference to FIG. 2 which is a profile view of the bonyanatomy of the rostral region of the horse's head. A more completediscussion of the relevant anatomy is disclosed in U.S. Pat. No.5,913,873, the entire disclosure having previously been incorporatedherein by reference. Briefly, the lateral free wall of the vestibule isdefined dorsally by the lateral aspect of the nasal bone 5, ventrally bythe incisive bone 6, and caudally by intersection 7 of the nasal 5 andincisive 6 bones. The rostral aspect of the vestibular free wall isbordered by the nostril (not shown).

[0060] The shaded area 8 in FIG. 2 depicts the approximate areaunderlying the “caudal apex region” of the vestibular wall. In someembodiments, a support device of the invention may be configured tosupport only the caudal apex region of the vestibular wall to facilitateair flow through the nasal passages. The caudal apex region is nearestthe nasal valve region of the nasal passages which is particularlyvulnerable to narrowing under certain conditions.

[0061]FIG. 3 is a bottom exploded view of NSD 10 illustrating a surfacelayer 11, support layer 12, engaging layer 13 and release liner 14. Acarrier layer is not shown in this view. FIG. 4a is a top plan view ofthe NSD 10 of FIGS. 1 and 3 showing rostral 21, intermediate 22 andcaudal 23 lift members in phantom lines. In this embodiment, thetransverse length T₂₁, T₂₂, and T₂₃ of lift members 21, 22, and 23,respectively, increases from the rostral end 3 to the caudal end 4 ofNSD 10. In addition, lateral engagement extensions 29, comprise rostral(30 a, 30 b), rostral/intermediate (31 a, 31 b), caudal/intermediate (32a, 32 b) and caudal (33 a, 33 b) lateral engagement extensions. Lateralengagement extensions 29 are comprised of surface layer 11 andengagement layer 12 which extend beyond the transverse length (i.e.,lateral extent) of lift members 21, 22, and 23 to facilitate engagementof NSD 10 to the nose of the animal. The functional aspects of thelateral engagement extensions can be embodied in various overall deviceappearances.

[0062]FIG. 4b is a top view of an alternative embodiment of the liftmembers of NSD 10. In this view only lift members 34, 35, 36 are shownand they are in the same relative position as shown in phantom lines inFIG. 4a. At the lateral extent of each of lift members 34, 35, 36. thereare pairs of notches 37 a-d, 38 a-c, 39 a-c which can penetrate througha partial or full thickness of each of the lift members 34, 35, 36. Inthe illustrated embodiment. four pairs of notches 37 a-d are present atthe lateral end of rostral lift member 34 and three pairs 38 a-c, 39 a-care present at the lateral end of intermediate lift member 35 and caudallift member 36. It will be appreciated that in this embodiment, the mostlateral notches 37 d, 38 c, 39 c of each lift member traverse a greaterportion of the width of the lift members (i.e., smaller unnotched regionbetween notches of a pair) than do notches nearer to midline M_(L) oflift members 34, 35, 36. The number of notch pairs can be varied.Typically, if additional notch pairs are added, they are added nearerthe midline M_(L) region of the lift member.

[0063] The effect of notches which traverse an increasing portion of thewidth dimension of the lift member from nearest the midline M_(L) to thelateral end is to gradually decrease the peel force exerted on theengaging layer between the support device and the animal's nose andconvert it to a shear force to facilitate engagement of the NSD 10 tothe animal's nose.

[0064] Referring to FIG. 3 release liner 14 can comprise a singlesection or have a single or multiple slits to make a multiple sectionrelease liner. Suitable release liners for use with an adhesive of theengagement layer are known. In one preferred embodiment, illustrated inFIG. 3, release liner 14 comprises three components, a first lateralpiece 40, a second lateral piece 41 and an intermediate piece 42.According to this embodiment, when applying NSD 10 to an animal's nose,intermediate piece 42 can be removed first and NSD 10 positioned overthe nasal bones 5, and the midline region 44 c of adhesive 44 ofengagement layer 13 lightly engaged to the skin over the nasal bones.Some repositioning can be performed before the lateral aspects 44 a and44 b of the adhesive 44 is exposed. Once the proper final position ofthe NSD 10 is determined, first lateral piece 40 and second lateralpiece 41 of release liner 14 can be removed and the lateral aspects 44 aand 44 b of adhesive 44 secured to the animal's nose.

[0065] In the embodiment of FIG. 3, the bottom side 50 of surface layer11 (i.e., the side towards the animal's nose when in use) includes anadhesive layer 51 to adhere the surface layer 11 to the top side 52 oflift members (21, 22, 23) and to the top side 54 of engaging layer 13.The bottom side 53 of lift members (21, 22, 23) can include an adhesive56 to adhere the lift members (21, 22, 23) to the top side 54 of theengaging layer. The bottom side 55 of engaging layer 13 includesadhesive 44 to adhere the device to the animal's nose. Each of theadhesives of NSD 10 can be a coated medical tape, transfer adhesive,liquid adhesive, PSA, etc. In one preferred embodiment, the surfacelayer 11 is 9910 black non-woven medical tape available from 3M Co., St.Paul, Minn., the lift members 21, 22, 23 are MYLAR® available fromDuPont Films, Wilmington, Del. the engaging layer 13 is DM-2009,available from Dermamed, Pallmadge, Ohio 44278 and the release liner isDM-2009 release liner, also available from Dermamed.

[0066] In some embodiments, an NSD can include a carrier layer. FIG. 5,is a top view of an NSD 10 including a carrier layer 60 which isreleasably adhered to the surface layer 11. In this embodiment, carrierlayer 60 follows the perimeter edge 51 of surface layer 11 except at therostral end 3 of the NSD 10. At the rostral end 3, the carrier layer 60includes a rostral extension 61. Rostral extension 61 provides agrasping portion 63, for handling NSD 10 with reduced likelihood ofcontacting the adhesive 44 of engagement layer 13, if the release linerhas been removed. In addition, in the embodiment of a carrier layer 60of FIG. 5, the rostral extension 61 is configured to provide analignment guide for proper positioning of the NSD 10 on an animal'snose. Specifically. by aligning the rostral edge 65 of carrier layer 60at the apex of a horse's nostrils, the side pieces 1 aand 1 b will beproperly aligned over the lateral vestibular walls. FIG. 6 is a frontview of an NSD 10 secured to the nose 70 of a horse 71.

[0067]FIG. 7 is an NSD 10 having an alternative embodiment of a carrierlayer 80 releasably adhered to the surface layer 11. As with carrierlayer 60 of FIG. 5, carrier layer 80 includes a rostral extension 81. Inaddition, carrier layer 80 also includes a caudal extension 82 tofacilitate handling and positioning of the device 10. In otherembodiments, the carrier layer could be configured to provide lateralextensions or a perimeter extension around the entire device.

[0068] A carrier layer and release liner as disclosed herein can also beused with human nasal support dilators as well as with animal nasalsupport devices as disclosed in, for example, U.S. Pat. No. 5,913,873and co-pending applications U.S. patent application Ser. Nos. 09/018,603and 09/264,464, the entire disclosures of which are being incorporatedherein by reference.

[0069]FIG. 8 is a top view of an alternative embodiment of an NSD 100according to the invention. Four lift members 101, 102, 103 and 104 areillustrated in phantom lines. It will be appreciated that in thisembodiment, lift member 101 at the rostral end 105 of NSD 100 has thelongest transverse dimension and lift member 104 at the caudal end 106has the shortest transverse dimension. Lateral engagement extensions 108a, 108 b and 109 a, 109 b are also present for purposes previouslydiscussed.

[0070]FIGS. 9 and 10, illustrate an alternative embodiment of a supportdevice and method of the invention. For exemplary purposes, thefollowing description will be made with illustrations of a supportdevice applied to the skeletal anatomy of a horse to appreciate therelative positions of the anatomy and the support provided.

[0071] The embodiments of FIGS. 9 and 10 provide localized support tothe caudal apex region of the vestibular wall. FIG. 9 illustrates thepositioning, relative to shaded area 8, of a support device 200 whenapplied to the caudal apex region of the vestibular wall. Asillustrated, support device 200 has a dorsal edge 201 which overlies aportion of nasal bone 5 and a ventral edge 202 which overlies a portionof incisive bone 6. The amount of dorsal edge 201 and ventral edge 202which overlies nasal bone 5 and incisive bone 6 is preferably at leastabout 0.5 cm and typically about 1.0 to 3.0 cm.

[0072]FIG. 10 illustrates an alternative embodiment for supporting thecaudal apex region of the vestibular wall. In this embodiment, supportdevice 300 extends caudally beyond the intersection 7 of nasal bone 5and incisive bone 6. Preferably, support device 300 extends about 0.5 cmto about 5.0 cm caudal to intersection 7. Support device 300 alsoextends dorsally and ventrally over nasal bone 5 and incisive bone 6,respectively, as described for support device 200.

[0073] It will be appreciated that although support device 200 isillustrated as a rectangle and support device 300 as a triangle, othershapes, including squares, circles, ovals, octagons, etc., can be usedto provide function according to this aspect of the invention. Inaddition, support devices 200 and 300 can include a carrier layer,surface layer, support layer, engaging layer and release liners asdescribed for other embodiments of the invention. The support layer cancomprise one or more lift members made of previously describedmaterials.

[0074] Thus, a support device as disclosed herein provides support forthe nasal passages of an animal, particularly unsupported soft tissues.The devices can provide reduced resistance to air flow, includingreduced turbulence, at rest and during exercise. In addition, thesupport devices can be used to treat or prevent respiratory ailments inadult or young animals.

[0075] Support of unsupported nasal tissues is particularly advantageousfor animals such as horses because horses are obligate nose breathers.In preferred embodiments, a herein disclosed NSD may reduce the amountof bleeding which is associated with exercise-induced pulmonaryhemorrhage (EIPH) in horses. Methods are known for determining theamount of pulmonary bleeding which occurs during EIPH. One such methodincludes performing pulmonary lavage post exertion and quantifying thenumber of red blood cells per microliter (i.e., RBC/μl) in the lavagefluid. In some embodiments, when a herein disclosed support device isworn during physical exertion by a horse susceptible to EIPH, pulmonaryred blood cell counts can be reduced by at least 5%, preferably by atleast 10-20%, in some embodiments by 30-40% and in some embodiments byat least 50-70% as compared to when the same horse is exercised withoutthe NSD.

[0076] Without being limited to a particular theory, the inventorsbelieve that support of the lateral vestibular wall, or portionsthereof, over the nasal region of an animal decreases resistance to airflow and increases breathing efficiency. That is, when wearing an NSD,less energy is consumed by the animal during inspiration or expirationof air into the lungs. Resistance to air inflow/outflow is reduced byproviding a cross sectional area of the nasal passages which is greaterthan the cross sectional area when the support device is not used. It isbelieved that a decrease in cross sectional area of the nasal passagesrequires an increase in intrapleural pressure (i.e., negative pressure)during inspiration to draw the same amount of air into the lungs. Airwayresistance (R) is related to the pressure (P) across the nasal airwaypassage and flow (F) of air through the nasal passage by the equation:R=P/F.

[0077] The inventors believe that a high intrapleural negative pressureacross pulmonary aveoli combined with high pulmonary blood pressureduring exercise can cause rupture of pulmonary blood vessels whichmanifests as EIPH.

[0078] In some embodiments, when a herein disclosed support device isworn during exercise by a horse. nasal passage resistance can be reducedby at least about 5-10%, typically 20-30)%, and in some animals, bygreater than 40%. In addition, by reducing nasal passage resistance,less work is required during breathing resulting in reduced oxygenconsumption and reduced CO₂, production for the same amount of exertion.Heart rate may also be reduced in a horse using an NSD when compared tothe same horse performing at the same level of exertion without an NSD.

[0079] Having now described the invention, it will be apparent to one ofskill in the art that changes and modifications can be made to theinvention without departing from the spirit or scope of the appendedclaims. All modifications and equivalents of the disclosed invention areintended to be included within the scope of the claims.

What is claimed is:
 1. A support device for supporting tissues overlyinga first and second nasal passage, the support device comprising: anengaging layer including an adhesive for engaging the support device tothe tissues; a surface layer; a support layer positioned between theengaging layer and surface layer; and a carrier layer releasably mountedto the surface layer.
 2. The support device according to claim 1 furthercomprising a release liner releasably attached to the adhesive of theengaging layer.
 3. The support device according to claim 2 wherein therelease liner comprises a first lateral piece. a second lateral piece,and an intermediate piece.
 4. The support device according to claim 1configured to include: a transverse axis having a transverse dimension;a center longitudinal axis having a center longitudinal dimension, thecenter longitudinal axis being orthogonal to the transverse axis and thecenter longitudinal axis bisects the transverse axis; a first and secondlateral longitudinal dimension on opposing sides of the centerlongitudinal dimension; the center longitudinal dimension greater thanthe first and second lateral longitudinal dimensions; the surface layeron opposing sides of the transverse axis being mirror images of oneanother.
 5. A support device according to claim 4 wherein the surfacelayer on opposing sides of the longitudinal axis are mirror images ofone another.
 6. A support device according to claim 1 wherein thesupport layer includes at least two lift members.
 7. A support deviceaccording to claim 1 wherein the support layer includes at least threelift members.
 8. A support device according to claim 7 having anengagement extension extending laterally beyond the lift members.
 9. Asupport device according to claim 4 wherein the support device isbilaterally symmetrical across both of the transverse and longitudinalaxes.
 10. A support device according to claim 1 wherein the surfacelayer is a dark color.
 11. A support device according to claim 1 whereinthe carrier layer includes a rostral extension.
 12. A support deviceaccording to claim 11 wherein the rostral extension is an alignmentguide.
 13. A support device for supporting tissues overlying a first andsecond nasal passage, the support device comprising: an engaging layerincluding an adhesive for attaching the support device to the tissues; asurface layer; a support layer positioned between the engaging layer andsurface layer; and a release liner releasably attached to the adhesivelayer, the release liner comprising a first lateral piece, a secondlateral piece, and an intermediate piece.
 14. A support device accordingto claim 13 further comprising a carrier layer releasably mounted to thesurface layer.
 15. A support device according to claim 13 wherein thesupport layer includes at least two lift members.
 16. A support deviceaccording to claim 13 having an engagement extension extending laterallybeyond the lift members.
 17. A support device according to claim 13configured to include: a first side piece for engaging a first lateralvestibular wall overlying a first nasal passage, the first side piecehaving a rostral end, a caudal end and a first rostral-poll dimension; asecond side piece for engaging a second lateral vestibular walloverlying a second nasal passage, the second side piece having a rostralend, a caudal end and a second rostral-poll dimension; a midline regionincluding an intersection of the first and second side pieces, themidline region having a rostral end, a caudal end and a midline regionrostral-poll dimension that is greater than either of the firstrostral-poll dimension and the second rostral poll dimension.
 18. Asupport device according to claim 13 wherein the support device isconfigured to fit the nose of a horse.
 19. A support device according toclaim 13 wherein the surface layer is a dark color.
 20. A support devicefor supporting tissues overlying a first and second nasal passage, thesupport device comprising: an engaging layer including an adhesive forattaching the support device to the tissues; a surface layer; a supportlayer positioned between the engaging layer and surface layer; and thesurface layer is a dark color.
 21. A method for facilitating air flowthrough the nasal passages of an animal, the method comprisingsupporting a caudal apex region of a vestibular wall overlying the nasalpassages of the animal.